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Auditory Processes and Emotional Perception in Schizophrenia (AUDISPACE)

Primary Purpose

Basic Auditory Processes, Emotional Perception, Source Monitoring Deficits

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cognitive experiments' session
Sponsored by
Hôpital le Vinatier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Basic Auditory Processes focused on measuring auditory processes, emotional perception, source monitoring, schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subjects aged between 18 and 65 years old - written given consent

For patients with schizophrenia:

- that meet the DSM-5.0 schizophrenia criteria

For healthy control subjects:

  • absence of psychiatric disroders (past and actual) diagnosed according to the DSM-5.0
  • absence of prodromal psychosis as measured by a score under 6 at the Prodromal Questionnaire PQ-16 (Ising et al., 2012)
  • absence of auditory disorders (actual and past) (including tinnitus)
  • absence of medical treatment (to the exception of contraceptive pills

Exclusion Criteria:

  • history of neurological disorders or brain injury with loss of consciousness
  • subjects presenting with highly developed musical abilities (frequently practicing a musical instrument)
  • subjects presenting with an intellectual deficiency as measured by the Raven progressive matrices
  • subjects under guardianship

Sites / Locations

  • Centre Hospitalier le VinatierRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Patient group with schizophrenia

Healthy control subjects

Arm Description

The schizophrenic subjects will undertake a 3 hour session of cognitive experiments. Tasks will include a battery of psychoacoustic tests, a source monitoring task, an externalization task, a pitch discrimination task and a speech-in-speech task.

Healthy control subjects will undertake a 3 hour session of cognitive experiments. Tasks will include a battery of psychoacoustic tests, a source monitoring task, an externalization task, a pitch discrimination task and a speech-in-speech task.

Outcomes

Primary Outcome Measures

Performance on a Reality monitoring task and on an externalization task
A computerized source memory task was designed for this study and a computerized externalization task was also designed (see description above). Rate of correct responses in both tasks is the main outcome.

Secondary Outcome Measures

Performance on a task measuring the impact of emotional stimuli on externalization processes
computerized externalization task. Emotional nonverbal bursts are presented, the azimuth is varied in order to create the impression of the sound coming either from inside or outside the head. Subjects have to determine whether the emotional nonverbal burst was perceived as coming from inside or outside their head. The rate of correct responses (in / out) is the outcome.
Performance on source separating paradigms
2 computerized tasks. - Vocal pitch discrimination task (30 min): pairs of vocal vowels are presented, subjects will have to determine if the pairs differ in pitch or not. The rate of correct responses is the outcome. - Speech-in-speech task (30 min): target words are presented simultaneously to masks composed of time reversed words (having lost their semantic content). Subjects have to listen and repeat the words heard. The rate of correct words heard is the outcome.
Performance on basic auditory tasks
a computerized psychoacoustic battery of tests, including a Tone Matching Task (evaluating nonverbal pitch), and other psychoacoustic tasks measuring amplitude, length of sound etc… The rate of correct responses is the outcome.

Full Information

First Posted
February 9, 2021
Last Updated
March 23, 2022
Sponsor
Hôpital le Vinatier
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1. Study Identification

Unique Protocol Identification Number
NCT04768335
Brief Title
Auditory Processes and Emotional Perception in Schizophrenia
Acronym
AUDISPACE
Official Title
Pilot Study: the Links Between Basic Auditory Processes and High Functioning Cognitive Processes in Schizophrenia (Reality Monitoring and Emotional Perception)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Schizophrenia is a mental illness with a variety of clinical symptoms that can be regrouped into 2 categories: positive and negative symptoms. This mental illness is also characterised by cognitive alterations in various fields, including social cognition difficulties and self / non-self-discrimination difficulties. Self and non-self-discrimination abilities have been regrouped under a function called source memory. This source memory enables a person to identify the source of an information previously encoded. In our everyday life, these processes are necessary to distinguish events generated by an external source from imagined events. It is called reality monitoring. A number of studies have evidenced reality-monitoring alterations in patients suffering from schizophrenia. More specifically, patients would present with an externalisation bias, they would assign more imagined events to an external source. The knowledge of these deficits encourages the study of the processes involved in order to better understand the alterations, particularly including auditory processes. A recent study has shown that discrimination errors concerning certain sound characteristics (e.g. frequency) were associated to reality monitoring errors. However, the links between reality-monitoring and basic auditory processes have rarely been explored. The dysfunction of the auditory "where" path, especially the possibility to discriminate between the intra and extra cephalic localisation of sounds, could lead to difficulties to discern between what is produced by one self and what is produced by another or the local environment.
Detailed Description
The main objective of this study is to study the links between source memory deficits and externalization abilities in schizophrenic patients and healthy subjects. Also, this study will: evaluate the impact of emotional content on the ability to externalize an auditory perception evaluate the abilities to separate sources concerning vocal stimuli evaluate the basic auditory processes In order to meet the objectives, the correlation between the percentage of good attributions in the reality monitoring task and the percentage of correct perceptions in/out (sound perceived as coming from inside or outside the head) will be analyzed in the externalization task in patients suffering from schizophrenia. Will also be analyzed: the number of correct perceptions In/Out in the externalization task the number of correct perceptions In/Out for the emotional stimuli the detection level of difference in pitch between 2 vocal sources pour the height discrimination task the number of correctly identified words in the speech-in-speech task The tasks : Subjects will undergo a battery of cognitive and auditory experiments in order to answer the objectives and hypothesis. The duration of the entire experiments will be 3.30 hours. - Subjects will undergo the source monitoring task (30 min): This task is divided in 2 parts: one part that will evaluate the reality monitoring performances (LISTENING task). Subjects either have to listen to words or imagine themselves listening to words another part evaluating internal source monitoring performances (SAY task). Subjects either have to pronounce words or imagine themselves pronouncing words. In order to measure perception abilities, all subjects will undergo a battery of psychoacoustic tests (30 min) including the Tone Matching Task (TMT) which evaluates the capacity of discriminating static pitch. The battery is also composed of tasks measuring length, amplitude, etc… A yes / no discrimination task will be used to measure the externalization abilities: subjects will have to discern whether a sound is perceived as coming from inside or outside the head the ability to separate sources will be measured using 2 paradigms: a pitch discrimination task (30 min): it will evaluate the capacity to discern sources based on voice pitch a speech-in-speech task (30 min): target words are presented simultaneously to masks (composed of words time reversed so that have lost the semantic content). The subject has to listen and repeat the words heard.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basic Auditory Processes, Emotional Perception, Source Monitoring Deficits
Keywords
auditory processes, emotional perception, source monitoring, schizophrenia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient group with schizophrenia
Arm Type
Active Comparator
Arm Description
The schizophrenic subjects will undertake a 3 hour session of cognitive experiments. Tasks will include a battery of psychoacoustic tests, a source monitoring task, an externalization task, a pitch discrimination task and a speech-in-speech task.
Arm Title
Healthy control subjects
Arm Type
Active Comparator
Arm Description
Healthy control subjects will undertake a 3 hour session of cognitive experiments. Tasks will include a battery of psychoacoustic tests, a source monitoring task, an externalization task, a pitch discrimination task and a speech-in-speech task.
Intervention Type
Behavioral
Intervention Name(s)
cognitive experiments' session
Intervention Description
The aim of this unique session of cognitive experiments is to study the links between source memory deficits and externalization abilities in healthy control subjects. Results of this Arm 2 will be compared to those of Arm 1.
Primary Outcome Measure Information:
Title
Performance on a Reality monitoring task and on an externalization task
Description
A computerized source memory task was designed for this study and a computerized externalization task was also designed (see description above). Rate of correct responses in both tasks is the main outcome.
Time Frame
one day
Secondary Outcome Measure Information:
Title
Performance on a task measuring the impact of emotional stimuli on externalization processes
Description
computerized externalization task. Emotional nonverbal bursts are presented, the azimuth is varied in order to create the impression of the sound coming either from inside or outside the head. Subjects have to determine whether the emotional nonverbal burst was perceived as coming from inside or outside their head. The rate of correct responses (in / out) is the outcome.
Time Frame
one day
Title
Performance on source separating paradigms
Description
2 computerized tasks. - Vocal pitch discrimination task (30 min): pairs of vocal vowels are presented, subjects will have to determine if the pairs differ in pitch or not. The rate of correct responses is the outcome. - Speech-in-speech task (30 min): target words are presented simultaneously to masks composed of time reversed words (having lost their semantic content). Subjects have to listen and repeat the words heard. The rate of correct words heard is the outcome.
Time Frame
one day
Title
Performance on basic auditory tasks
Description
a computerized psychoacoustic battery of tests, including a Tone Matching Task (evaluating nonverbal pitch), and other psychoacoustic tasks measuring amplitude, length of sound etc… The rate of correct responses is the outcome.
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects aged between 18 and 65 years old - written given consent For patients with schizophrenia: - that meet the DSM-5.0 schizophrenia criteria For healthy control subjects: absence of psychiatric disroders (past and actual) diagnosed according to the DSM-5.0 absence of prodromal psychosis as measured by a score under 6 at the Prodromal Questionnaire PQ-16 (Ising et al., 2012) absence of auditory disorders (actual and past) (including tinnitus) absence of medical treatment (to the exception of contraceptive pills Exclusion Criteria: history of neurological disorders or brain injury with loss of consciousness subjects presenting with highly developed musical abilities (frequently practicing a musical instrument) subjects presenting with an intellectual deficiency as measured by the Raven progressive matrices subjects under guardianship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lydie SARTELET
Phone
0437915531
Ext
+33
Email
lydie.sartelet@ch-le-vinatier.fr
Facility Information:
Facility Name
Centre Hospitalier le Vinatier
City
Bron
ZIP/Postal Code
69678
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marine Mondino
Phone
0437915565
Ext
+33
Email
marine.mondino@ch-le-vinatier.fr
First Name & Middle Initial & Last Name & Degree
Jérôme Brunelin
Phone
0437915297
Ext
+33
Email
jerome.brunelin@ch-le-vinatier.fr
First Name & Middle Initial & Last Name & Degree
Marine Mondino
First Name & Middle Initial & Last Name & Degree
Gabrielle CHESNOY
First Name & Middle Initial & Last Name & Degree
Frédéric Haesebaert
First Name & Middle Initial & Last Name & Degree
Jerome Brunelin

12. IPD Sharing Statement

Plan to Share IPD
No

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Auditory Processes and Emotional Perception in Schizophrenia

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